Z-0886-2008

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387310...

Name: Z-0886-2008 Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387310...
Creator: Argon Medical Devices, Inc
Published: 2007-11-19
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2007-11-19 / Terminated / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387310, .035/150cm, stiff/angled/standard, sold as a single... on 2007-11-19. The reason FDA records is "Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0886-2008
Status: Terminated
Initiated: 2007-11-19
Posted: 2008-01-31
Terminated: 2008-06-05
Recalling firm: Argon Medical Devices, Inc
Product: Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387310, .035/150cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
Product code: DQX Wire, Guide, Catheter
Reason for recall: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Argon Medical sent an Urgent Product Recall letter to consignees on 11/15/2007. They requested that users immediately quarantine and return any product remaining at their facility, utilizing instruction on response card. Distributors were directed to issue the recall to their customers and return all retrieved product to Argon.
Quantity in commerce: 1,014
Distribution: Worldwide Distribution -- USA including states of FL, KS, NV, IL, CA, NY, CO, VA, MD, NC, UT, GA, MI, NJ, TN, MA, and CT, and countries of The Netherlands, Germany, and Turkey.
Product codes and lots: Lot Numbers: 99504912, 99509169, and 99534483

Product code DQX

K011905Class IISniper Elite Model-or-E3872xx SeriesMaxxim Medical / cleared 2001-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)